Issue link: https://beckershealthcare.uberflip.com/i/1119391
40 Executive Briefing: Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. For more information, visit www. metronic.com or call (901) 396-3133 (800) 876- 3133 / (800) 933-2635. appropriate treatment and follow-up protocol. The panel suggested a shorter wait time between diagnosis and pursuing interventional treatment. 9 "Historically, clinicians waited for weeks to see whether physical and/or other elements of conservative therapy would fail before moving on to more aggressive treatment," Dr. Hirsch said. "However, in this study the experts believed by and large that waiting an artificial length of time while patients' health declined wasn't a good thing. It was interesting to see expert consensus solidify as an idea that hasn't been previously articulated." The RAND/UCLA paper provides clinicians with an evidence- based clinical care pathway to identify symptomatic patients and direct them to the most appropriate care. The fact that the report was double-blinded doesn't mitigate that the panel process has subjective input. However, it can be noted that strict adherence by the multidisciplinary experts to adopt the RAND™ methodology process based on published clinical evidence and expertise was observed. VCF Clinical Care Pathway project was supported by a grant from Medtronic. However, Medtronic was not involved in the design or execution of the project, nor the preparation and review of this manuscript. Names of panel members were not disclosed to the sponsor, and panel members were not informed about the identity of the sponsor before submission of the manuscript. Clinical patient results A strong body of literature supports vertebral augmentation for VCF patients, and clinicians across the treatment spectrum agree early intervention is appropriate in selected patients. As more clinicians and non-spine specialists are educated about diagnosing and treating VCF, patients will have increased access to interventional treatment options. "Patients tend to be extremely strong advocates of the procedure," Dr. Hirsch said. "It's also gratifying for the physician due to the patient outcomes; it's a very rewarding procedure, professionally." Hospitals and health systems across the country are at various stages of integrated care for back and neck pain. Whereas the infrastructure already exists at larger, multidisciplinary organizations to implement a clinical care pathway, smaller organizations can influence referral patterns and outcomes by implementing a similar structure. "Institutions can develop their own clinical care pathways and successfully gain consensus at an organizational level. There is also a societal opportunity where big organizations that represent multiple specialists can bring together disparate experts to develop care pathways," Dr. Hirsch said. "Our recommendations provide a substrate for big and small institutions, providers and networks to standardize referral patterns and care pathways for vulnerable patients. If we can optimize their care pathway on the macroscopic level, it will have an affect at the patient care level." About Balloon Kyphoplasty (BKP) BKP is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. The complication rate with BKP has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as: cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism, or cardiac embolism. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product. For more information on VCF Carepathway visit: medtronic. com/vcfcarepathway For more information on VC Mortality Risk visit: medtronic. com/bkpmortality References 1 Hirsch JA, Beall DP, Chambers MR, et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018. doi: 10.1016/j.spinee.2018.07.025. 2 Hirsch JA, et. al. 3 Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P. Wriedt C, et al. A Randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J med 2009;361: 557-68. ; Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361: 569-79. 4 Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P. Wriedt C, et al. A Randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J med 2009;361: 557-68. 5 Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361: 569-79. 6 Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009 publication of vertebroplasty 'sham' trials? Osteoporos Int 2018;29:375-83. 7 (a) Ong KL, Beall DP, Frohbergh M et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials. Osteoporos Int. 2017 Oct 24. doi: 10.1007/s00198-017-4281-z. (b) Edidin AA, Ong KL, Lau E, Kurtz SM. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population. J Bone Miner Res. 2011 Jul;26(7):1617-1626. doi: 10.1002/JBMR.353. PubMed PMID: 21308780. (c) Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2013 Oct 2;95(19):1729-1736. doi: 10.2106/JBJS.K.01649. PubMed PMID: 24088964. (d) Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine. 2014 Feb 15;39(4): 318-326. doi: 10.1097/BRS.00135. PubMed PMID: 24299715.(e) Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and non-operative management in the Medicare population. Spine. 2015 Aug 1;40(15):1228-1241. doi: 10.1097. PubMed PMID: 26020845. (f) McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs. conservative therapy. JAMA Intern Med. 2013 Sep 9;173(16):1514-1521. doi: 10.1001/jamainternmed.2013.8725. PubMed PMID: 23836009; PubMed Central PMCID: PMC4023124. 8 Hirsch JA, et al. 9 Hirsch JA, et al. PMD022530-1.0 / UC201912667 EN